Trial Outcomes & Findings for A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS) (NCT NCT01998269)

NCT ID: NCT01998269

Last Updated: 2015-04-02

Results Overview

The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.

• Recruitment status: COMPLETED
• Target enrollment: 210 participants
• Primary outcome timeframe: cross-sectional, 1 hour interview after clinic visit
• Results posted on: 2015-04-02

Participant Flow

A total of 210 patients were recruited from the University of North Carolina Ambulatory Care Center. 17 patients participated in focus groups to help develop the medication self-management tool (MeDS tool). The other 193 participated in item performance testing. The results of item performance testing are reported here.

Participant milestones

Measure	Adult Patients With Diabetes and Hypertension English-speaking, adult patients with diabetes and hypertension. There are no study arms - this was a cross-sectional study to develop and validate a measure of medication self-management skills. A total of 210 patients were recruited. 17 participated in focus groups to help develop the tool. The other 193 participated in item performance testing. The results of item performance testing are reported here.
Overall Study STARTED	193
Overall Study COMPLETED	193
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS)

Baseline characteristics by cohort

Measure	Adult Patients With Diabetes and Hypertension n=193 Participants There are no study arms. This was a cross-sectional study to develop a scale.
Age, Continuous	61.1 years n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	105 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: cross-sectional, 1 hour interview after clinic visit

The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.

Outcome measures

Measure	Adult Patients With Diabetes and Hypertension n=179 Participants English-speaking, adult patients with diabetes and hypertension were enrolled in the study. There are no study arms.
Measure of Medication Self-Management (MeDS) MeDS tool	10.9 units on a scale Standard Deviation 2.6
Measure of Medication Self-Management (MeDS) Morisky Adherence Measure	2.5 units on a scale Standard Deviation 1.7

Adverse Events

Adult Patients With Diabetes and Hypertension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stacy Bailey

University of North Carolina at Chapel Hill

Phone: 919-843-9834

Email: scbailey@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60